Agents for the treatment and protection of the skin

ABSTRACT

The present invention relates to a method for the treatment and protection of human and animal skin which contains vitamin E in a high dose and, in addition, may optionally further contain vitamin C, vitamin A, vitamins of the B series, blood circulation-promoting agents and/or vasodilators, phospholipids, unsaturated fatty acids and/or emulsifiers.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.07/518,565 filed May 3, 1990, now abandoned which is a divisionalapplication of U.S. Ser. No. 07/211,125, filed Jun. 21, 1988, U.S. Pat.No. 4,938,960, which is a continuation of U.S. Ser. No. 06/900,727,filed Aug. 27, 1986, abandoned, which is a continuation-in-part of U.S.Ser. No. 06/706,723, filed Feb. 28, 1985, abandoned.

BACKGROUND OF THE INVENTION

The present invention relates to an agent containing vitamin E fortreating and protecting the skin.

Vitamin E is known as an antioxidant and protective vitamin forphospholipids of the cell membrane. It maintains the permeability andstability of the cell membrane; cf. Lucy, Annals N.Y. Academy of Science203, p. 4 (1972). There has further been known that vitamin E has amembrane-sealing effect; cf. F. Mittelbach and G. Bodechtel, MunchnerMedizinische Wochenschrift 110 (1968) 36: pp. 1988-1993. Inerythrocytes, the simplest cells of the human body, there has been foundthat vitamin E provides a protective effect for the cell membrane. Intests with animals and humans it has been proven that anemia is a firstsignal of a deficiency of vitamin E. The hemolysis of the erythrocyteswill normalize upon administration of high doses of vitamin E; cf.William J. Darbey Vitamin Horm., 26 (50) pp. 685-704 (1968) and PhelpsDL Pediatrics 63 (6) pp. 933-935 (1979). From these references from theliterature there is apparent that after the oral administration of from200 to 800 mg of vitamin E over a period of from 1 to 4 days thehemolysis of the erythrocytes is significantly improved as compared topatients suffering from vitamin E deficiency.

Vitamin E has further been used to treat sickle cell anemia over aperiod of from 6 to 35 weeks; cf. Natt CL. Am. J. Clin. 33, pp. 968-971(1980); Natt CL. Am. J. Clin. Nutr. 32, pp. 1359-1362 (1979); Gawlik G.M. Fed. Proc. 35 (3), p. 252 (1976) and Gorash L. Bieri J. G. et al.Univ. Conn. Farmington, GT.

It has further been known that a daily dose of 750 mg of vitamin E overa period of from 3 to 6 months was successfully used to treatthalassemia patients, whereupon a normalization of the hemolysis of theerythrocytes was observed; cf. Kahane I. ISR. J. Med. 12 (1), pp. 11-15(1976).

Vitamin E has further been successfully applied to patients sufferingfrom an acute hepatitis or an alcoholic hepatitis who have a deficiencyin vitamin E in serum; cf. Yoshiakawa T., Takemura S., Karo H. et al.,Japan. J. Gastrovent, 74/7, pp. 732-739 (1977). Eventually, vitamin Ehas been used to treat patients suffering from anemia due to an irondeficiency, in which treatment it caused an improvement or normalizationof the lipid metabolism in the bone marrow to occur in the course offrom 4 to 8 weeks; cf. Takoshi Itaga, Central Clinical LaboratoryNagasaki University of Medicine, Japan.

In the German Patent Applications P 34 20 738, P 34 05 928, P 34 05 239,P 34 07 025, P 34 08 260, P 34 16 162, P 34 32 881, P 34 05 240, P 34 02930, P 34 07 024, P 34 07 026, P 34 15 250, P 34 27 193 the use ofvitamin E has further been proposed for the treatment of the veins, ofthe anal region and of rheumatic diseases.

It has further been known that cholesterol in human and animal skin isconverted by ultraviolet radiation into cholesterol-alpha-oxide, asubstance known to be carcinogenic. Experiments with mice have shownthat upon administration of vitamins E and C and of two furtherantioxidants no cholesterol-alpha-oxide will be formed (Pharm. Indu. 36,Nr. 3 (1974) Anschel, USA).

It has now surprisingly been found that vitamin E and combinationscomprising vitamin E together with other active substances, morespecifically, are suitable as agents for the treatment of eczema, skintetter, skin inflammations, itch, allergies, wrinkles, pigmentations inthe skin, and alopecia as well as wounds. Moreover, the agents accordingto the invention can be employed as protective agents againstultraviolet light and for promoting hair growth. The agents according tothe invention are further suitable as skin-protecting agents in cases ofexposure to radiation, e.g. of cancer patients. This new range ofindications was not foreseeable from the state of the art and will opena new wide field of applications for vitamin E. The use of vitamin E, atlong sight, will result in a stabilization and permanent elimination ofthe symptoms, so that the probability of a relapse is very low. However,the combination preparations containing vitamin E will have to be takenover an extended period of time, for about 6 months or longer.

SUMMARY OF THE INVENTION

Thus, it is the object of the present invention to provide agentscontaining vitamin E for use in the treatment and for the protection ofhuman and animal skin, which agent is characterized in that it containsa high dose of vitamin E as the essential ingredient in addition toconventional carriers and/or excipients and, optionally, vitamin C,vitamin A, vitamins of the B series, blood circulation promoters and/orother vasodilators, phospholipids, unsaturated fatty acids and/oremulsifiers.

DETAILED DESCRIPTION OF THE INVENTION

Since vitamin E is liquid at room temperature, the capsule offers itselfas a form of application in the first place. The other activeingredients are incorporated in vitamin E and, if desired, in a readilyliquid neutral oil and a solutizer and introduced into the capsules in aper se known manner. Here emulsifiers such as, e.g., Tween, may be used.

In the agents according to the invention, above all, a sufficient dosageof vitamin E which should be at least 200 mg is crucial for the efficacyof vitamin E. Lower dosages of vitamin E are useless, since large partsthereof are destroyed by the gastric acid and thereby lose theiractivity; cf. Arthur Vogelsang, in: Angiology 21, pp. 275-279 (1970).

If, in the past, sometimes low amounts of vitamin E, viz. up to 40 mg,have been employed in combination preparations, these amounts withcertainty were ineffective due to the low doses. For the treatment, thedosage should be in the range of from 200 to 1,000 mg. Preferably dosageforms containing from 250 to 600 mg of vitamin E are used. Typicalcombination preparations contain from 300 to 500 mg of vitamin E perdosage unit.

Vitamin E may be employed in all of its alpha-forms, as the freetocopherol as well as its ester of natural origin or of syntheticorigin. Said ester can be the acetate, succinate or any other suitableester. For an ointment, gel or cream, respectively, the free tocopherol,such as D,L-alpha-tocopherol or D-alpha-tocopherol, is preferred to beused.

Surprisingly, the action of vitamin E is significantly increased in thepresence of vasodilators and/or blood circulation-promoting agents bysynergism, and thereby the duration of treatment is shortened.

Also unexpectedly, the absorption of vitamin E through the skin is alsoparticularly increased by the presence of agents promoting bloodcirculation such as heparin sodium, Extract. Hippocastani etc. Whenheparin sodium is used, the high dose of from 30,000 to 150,000 I.U. ispreferred.

Further agents which will essentially increase the action of vitamin Eand, hence, can be used for the present invention are agents promotingthe blood circulation such as B-Hydroxyethylrutoside, trimethylrutoside,Extract. Arnicae, nicotinic acid, nicotinic acid ester and derivativesthereof, xanthinol nicotinate, inositol nicotinate, and salicylic acidor the esters thereof, dihydroergotoxine methanesulfonate,dihydroergocornine methanesulphonate, dihydroergocristinemethanesulphonate, B-hydroxyethylsalicylate, 01. juniperi, 01. pinipumilionis (dwarf pine oil), 01. eucalypti, 01. rosmarinae, Tinct.camphorae (or camphor, respectively), Cinnarizine, Vincamine,Pentoxifylline, Bamethan sulfate, Bencyclan hydrogenfumarate,beta-pyridylcarbinol, Ginkgo flavoglycosides. Further derivatives of theagents promoting blood circulation and vasodilators may also be used.

As vegetable vasodilators there are to be mentioned, e.g., Extract.calendulae from Herba calendulae. The agents promoting blood circulationmay also be used in their retard forms (sustained release drugs).Numerous blood circulation-promoters, such as B-hydroxyethylrutoside,also have anticoagulant properties.

The combinations comprising sufficient amounts according to theinvention further improve the blood circulation in the extremities, theeye periphery, the inner ear and the cerebrum. If dimethylaminoethanolor its derivatives or salts, respectively, will further be added to thecombinations according to the invention, the blood flow in the brain, inthe central nervous system and the concentrating ability are enhanced.

The combinations according to the invention further have advantageouseffects on the lipid and cholesterol metabolisms.

The agents according to the invention may also be externally applied inthe form of a cream, gel, ointment or lotion or a solution, optionallytogether with emulsifier(s). In this case the concentration of vitamin Eis from 0.5 to 20% by weight. Amounts of from 4 to 10% by weight areparticularly preferred. Other administration forms may also be prepared,e.g. spray, tincture or an alcoholic solution. Isopropanol or propanediol are particularly preferred solvents which, at the same time,promote blood circulation as well. In this case, the concentration ofvitamin E may amount up to 32% by weight. A concentration of up to 25%by weight per administration form is preferred.

As the conventional bases for ointments or creams there may be usedEucerin cum aqua, Ungentum Cordes or Ungentum emulsificans as well asother water-insoluble ointment bases and mixtures thereof. For example,suitable ointment bases are wool wax, petrolatum DAB 8, highly fluidparaffin and mixtures thereof. They may also contain emulsifiers such ascetylstearylalcohol. Also suitable as bases for ointments are Unguentumalcoholum lanae aquosum containing Cetiol (oleyl oleate) and Unguentumlanette, cetylstearylalcohol, Cetiol DAB 8 and Aqua conservata.

Advantageously, further vitamins, e.g. the vitamins C, A, B₁, B₂ and B₆,may be added to the agents according to the invention.

An ointment according to the invention desirably contains the followingcomponents as the base materials: 70 to 30% by weight, preferably 60 to40% by weight, of water, 30 to 5% by weight, preferably 25 to 7% byweight, of Cetiol (oleyl oleate), and 30 to 2% by weight, preferably 25to 2% by weight, of cetylstearylalcohol or other aliphatic alcohols.

The cetylstearylalcohol altogether or in part may be replaced by otheremulsifying alcohols, such as, e.g., aliphatic alcohols or wool waxalcohols or diols, respectively, stearinol, monoglycerides esterifiedwith aliphatic acids or similar substances. There may also be added,e.g., paraffin or petrolatum or other suitable materials in order torender the ointment spreadable. Cetiol (oleyl oleate) may also becompletely or partially replaced by other emulsifiers such as Tween 20or Tween 80 etc. A particularly preferred combination as a base forointments or creams containing vitamin E is as follows:

30 to 20% by weight of cetylstearylalcohol,

20 to 10% by weight of Cetiol (oleyl oleate),

60 to 40% by weight of water (aqua conservata).

It has been known that ointment bases containing water such as Unguentumemulsificans aquosum and Unguentum alcoholum lanae aquosum are suitablefor processing water-soluble active substances. However, it issurprising that ointment bases containing water to an amount ofapproximately more than 50% are very well suitable for processinglipophiiic active substances such as vitamin E.

It has also unexpectedly been found that the agents according to thepresent invention are particularly beneficial if these agentsadditionally contain vitamin A. More specifically, the duration of thetreatment will be shortened. Thus, the present invention includes thoseagents for the treatment and protection of the skin that contain vitaminA together with vitamin E and blood circulation-promoting agents.Vitamin A can be employed as vitamin A palmitate, vitamin A acetate, afurther ester of vitamin A and/or as beta-carotene. The amount ofvitamin A in the dosage unit is to be selected so that the maximum dailydose will not exceed 50,000 I.U., i.e. when two dosage units are to beadministered per day, the dosage unit should contain a maximum of 25,000I.U. The dose of vitamin A in the agents according to the inventionusually is between 5,000 and 25,000 I.U., and preferably between 6,000and 15,000 I.U.

The vitamins A and E very strongly tend to clogging in an aqueousmedium, more particularly so in the presence of other active substances.Thus, it may happen that the lipophilic valuable substances are notabsorbed. There has now been determined that surprisingly small amountsof about 1% of an emulsifier are sufficient to prevent clogging. Theactive substances are more readily dispersed or suspended, respectively,in the aqueous medium. This is advantageous in that the absorption bythe intestine is facilitated. A higher amount of emulsifier is notnecessary, as in most cases 1 to 7% will suffice to prevent clogging.Emulsifiers may be used in amounts up to 10% or even more, but theselarger amounts have the drawback that side-effects may possibly occurwhen the medicament is administered over an extended period of time.

Conventional emulsifiers as used in medical preparations can beemployed, such as Tween 20, Cremophor®, aliphatic alcohols, partiallyesterified triglycerides etc. However, in the present invention Tween 80and Cetiol are preferred. It has been observed that upon the addition ofabout 10% of emulsifier the emulsification is not substantially improvedover that effected by the addition of 5% of emulsifier.

Lecithin in a concentration between 1 and 13% may also be used asemulsifier. This favors the resorption of the combination of vitamins Aand E and more specifically the resorption of vitamin A. Although uponthe use of large amounts of lecithin, up to 50%, a positive effect isdeterminable, small amounts of lecithin will suffice to prevent cloggingof the lipophilic vitamins and to positively affect the optimalresorption. It is further recommended to add about 1% of a conventionalemulsifier such as Tween 80, as thereby, the miscibility of lecithinwith the two vitamins is positively affected and clogging is prevented.With respect to the resorption properties the use of conventionalemulsifiers such as, e.g. Tween 80, in an amount of about 1% togetherwith from 1 to 13% of lecithin is particularly beneficial. There mayalso be used Tween 20, Cetiol (oleyl oleate) and Cremophor® types. Asthe lecithin preparation the soybean lecithin is preferred.

The agents according to the invention are also suitable as protectivesagainst ultraviolet light. For this purpose UV stabilizers are addedwhich are compatible with the skin and lipophilic as well as hydrophilicsuch as, e.g., Eusolex® (UV-Light Filters). The UV stabilizers can beadded in an amount of from 0.1 to 20% by weight, and preferably of from0.5 to 10% by weight.

Further possible additives include cod liver oil and/or unsaturatedfatty acids, e.g. linoleic acid, linolenic acid or oleic acid. Insteadof the unsaturated fatty acids there may also be used silicone oils orpolysiloxanes.

The agents according to the invention are particularly suitable asskin-protective agents when combined with phospholipids, e.g. withlecithin. The phospholipids will accelerate the absorption of vitamin Eby the skin and, thereby, increase the efficacy of the vitamin Epreparations.

In order to treat skin inflammations there may further be added up to12% by weight, based on the dosage unit, of Bufexamac to the vitamin Epreparations according to the invention, 3 to 10% by weight beingpreferred.

It has been known that Bufexamac cream or ointment is suitable for thetreatment of skin inflammations, allergies, eczema and itch. However,the duration of the treatment is surprisingly shortened in the presenceof vitamin E, and the probability of a relapse to occur is reduced.After the subsidence of the disease rubbing with only a vitamin Eointment is preferred to prevent a relapse.

For the treatment of allergies the agents according to the invention maybe combined with active antiallergic substances, more specificallyantihistaminics. An addition of vitamin E to those antiallergicallyactive materials accelerates the healing process.

As the antiallergic active substances there are used, for example,clemastine hydrogenfumarate, chlorphenoxamine hydrochloride, dimetidinemaleate, bamipine lactate or hydrochloride or other salts or esters,propylhexedrine hydrochloride, tritoqualine, and dephenhydraminemeclozine hydrochloride.

The agents according the present invention may also serve to promotehair growth, more specifically so if amino acids have been addedthereto.

The agents according to the present invention contain the conventionalcarrier material and excipients in addition to vitamin E. This fact isparticularly relevant to the agents for an intended externalapplication.

The present invention is further illustrated by the followingnon-limiting examples showing typical combinations of active substancesand dosages.

EXAMPLE 1

100 g of an ointment contain

400 mg of allantoin;

400 mg of Dexapanthenol;

5,000 mg of D-alpha-tocopherol;

30,000 I.U. of heparin sodium.

EXAMPLE 2

100 g of an ointment contain

2.5 g of O-(B-hydroxyethyl) rutoside;

6.5 g of D-alpha-tocopherol or D,L-alpha-tocopherol.

EXAMPLE 3

100 g of an ointment contain

400 mg of allantoin;

400 mg of Dexapanthenol;

8.8 g of D-alpha-tocopherol or D,L-alpha-tocopherol;

30,000 I.U. of heparin sodium.

EXAMPLE 4

100 g of an ointment contain

4.5 g of Extract. Hippocastani (contains about 800 mg of escin);

5.0 g of D-alpha-tocopherol.

EXAMPLE 5

100 g of a gel contain

50,000 I.U. of heparin sodium;

12 g of Arnica flower extract ((1:10), alcohol 60%);

25 g Tinct. Hippocastani e sem. (1:1, equals 0.65 g of escin);

7.5 g of D-alpha-tocopherol.

EXAMPLE 6

100 g of a gel contain

7.0 g of B-hydroxyethyl salicylate;

7.0 g of D-alpha-tocopherol.

EXAMPLE 7

100 g of an ointment contain

10 g of benzocain (anesthesin);

8 g of D-alpha-tocopherol-concentrate;

1 g of benzyl nicotinate.

EXAMPLE 8

100 g of an ointment contain

3 g of B-hydroxyethyl salicylate;

1 g of benzyl nicotinate;

7 g of D-alpha-tocopherol.

EXAMPLE 9

100 g of an ointment contain

8 g of D-alpha-tocopherol;

400 mg of allantoin;

400 mg of Dexapanthenol;

150,000 I.U. of heparin sodium.

EXAMPLE 10

One capsule contains

250 mg of nicotinic acid;

400 mg of D,L-alpha-tocopherol acetate;

150 mg of soybean oil.

EXAMPLE 11

One capsule contains

200 mg of B-hydroxyethyl rutoside;

300 mg of D,L-alpha-tocopherol acetate;

180 mg of soybean oil.

EXAMPLE 12

One capsule contains

150 mg of Extract. Hippocastani (contain 25 mg of escin);

300 mg of D,L-alpha-tocopherol acetate;

150 mg of soybean oil.

EXAMPLE 13

One capsule contains

300 mg of xantinol nicotinate;

400 mg of D-alpha-tocopherol;

190 mg of soybean oil.

EXAMPLE 14

One capsule contains

150 mg of Extract. Hippocastani (contain 25 mg of escin);

250 mg of vitamin E;

150 mg of soybean oil.

EXAMPLE 15

One capsule contains

5 mg of vitamin B₁ ;

5 mg of vitamin B₂ ;

5 mg of vitamin B₆ ;

200 mg of B-hydroxyethyl rutoside;

300 mg of vitamin E;

50 mg of nicotinic acid amid;

200 mg of soybean oil.

EXAMPLE 16

One capsule contains

100 mg of nicotinic acid;

100 mg of extract from horse-chestnuts (contain 16 mg of escin);

300 mg of D-alpha-tocopherol acetate;

200 mg of soybean oil.

EXAMPLE 17

One capsule contains

200 mg of inositol nicotinate;

300 mg of D-alpha-tocopherol concentrate;

150 mg of soybean oil.

EXAMPLE 18

One capsule contains

50 mg of procaine hydrochloride;

400 mg of D-alpha-tocopherol concentrate;

150 mg of soybean oil.

EXAMPLE 19

50 mg of procaine hydrochloride;

400 mg of D,L-alpha-tocopherol acetate;

5 mg of vitamin B₁ ;

5 mg of vitamin B² ;

5 mg of vitamin B₆ ;

150 mg of soybean oil or corn oil.

EXAMPLE 20

Drops:

100 ml of 90% Ethyl alcohol contain

40 g of D,L-alpha-tocopherol acetate;

4.5 g of Extract. Hippocastani (contain 750 mg of escin).

EXAMPLE 21

One capsule contains

4.5 mg of dihydroergotoxine methanesulfonate;

400 mg of D,L-alpha-tocopherol acetate.

EXAMPLE 22

One capsule contains

50 mg of procaine hydrochloride;

200 mg of nicotinic acid;

400 mg of vitamin E;

150 mg of corn oil.

EXAMPLE 23

One capsule contains

150 mg of bencyclane hydrogenfumarate;

400 mg of vitamin E as D,L-alpha-tocopherol acetate;

150 mg of soybean oil.

EXAMPLE 24

One capsule contains

    ______________________________________                                        Pentoxifyllin   400          mg;                                              vitamin E       400          mg;                                              vitamin A acetate                                                                             15,000       I.U.;                                            soybean oil     120          mg.                                              ______________________________________                                    

EXAMPLE 25

One capsule contains

    ______________________________________                                        Naftidirofuryl hydrogenoxalate                                                                    100        mg                                             vitamin E           500        mg                                             vitamin A palmitate 30,000     I.U.                                           soybean oil         150        mg.                                            ______________________________________                                    

EXAMPLE 26

One capsule contains

    ______________________________________                                        Cinnarizine            75        mg;                                          vitamin E              400       mg;                                          vitamin A palmitate    15,000    I.U.;                                        vitamins B.sub.1, B.sub.2, B.sub.6 (in equal amounts)                                                10        mg;                                          vitamin B.sub.12       5         mg;                                          soybean oil            150       mg.                                          ______________________________________                                    

EXAMPLE 27

100 ml of drops contain in ethylalcohol

    ______________________________________                                        Cinnarizine      7.5          g;                                              vitamin E        4.0          g;                                              vitamin A palmitate                                                                            2,500,000    units.                                          ______________________________________                                    

EXAMPLE 28

One capsule contains

    ______________________________________                                        xantinol nicotinate   500       mg;                                           vitamin E (D.L-alpha-tocopherol)                                                                    400       mg;                                           vitamin A Palmitat    10,000    I.U.                                          Tween 80              20        mg;                                           soybean oil           150       mg.                                           ______________________________________                                    

EXAMPLE 29

100 ml of drops contain in ethylalcohol dihydroergotoxinemethanesulfonate 1.5 g (comprising

0.5 g of dihydroergocristine methanesulfonate,

0.5 g of dihydroergocornine methanesulfonate,

0.333 g of alpha-dihydroergocryptine methansulfonate and

0.167 g of B-dihydroergocryptine methanesulfonate); vitamin E(D,L-alpha-tocopherol acetate) 3.5 g; vitamin A palmitate 2,500,000units.

EXAMPLE 30

One capsule contains

    ______________________________________                                        B-pyridyl carbinol tartrate                                                                           360      mg                                           (conforming to 150 mg of pyridylcarbinol);                                    D-alpha-tocopherol acetate                                                                            400      mg;                                          vitamin A palmitate     12,000   I.U.                                         soybean oil             150      mg.                                          ______________________________________                                    

EXAMPLE 31

One capsule contains

    ______________________________________                                        DL-alpha-tocopherol                                                                             400         mg;                                             B-hydroxyethyl rutoside                                                                         300         mg;                                             vitamin A palmitate                                                                             15,000      I.U.                                            soybean oil       150         mg.                                             ______________________________________                                    

EXAMPLE 32

One capsule contains

    ______________________________________                                        Ginkgo flavoglycosides 3.0      mg;                                           vitamin E DL-alpha-tocopherol acetate                                                                300      mg;                                           vitamin A palmitate    25,000   I.U.;                                         soybean oil            100      mg.                                           ______________________________________                                    

EXAMPLE 33

One capsule contains

    ______________________________________                                        nicotinic acid    300         mg;                                             vitamin E         400         mg;                                             vitamin A palmitate                                                                             15,000      I.U.;                                           Cetiol (oleylic acid ester)                                                                     20          mg;                                             soybean oil       150         mg.                                             ______________________________________                                    

EXAMPLE 34

One capsule contains

    ______________________________________                                        DL-alpha-tocopherol acetate                                                                       400        mg;                                            B-Hydroxyathylrutosid                                                                             300        mg;                                            vitamin A palmitate 25,000     I.U.;                                          soybean oil         120        mg.                                            ______________________________________                                    

EXAMPLE 35

One capsule contains

    ______________________________________                                        Pentoxifylline         400      mg;                                           vitamin E DL-alpha-tocopherol acetate                                                                400      mg;                                           vitamin A palmitate    15,000   I.U.;                                         Tween 80               10       mg;                                           soybean oil            150      mg.                                           ______________________________________                                    

EXAMPLE 36

One capsule contains

    ______________________________________                                        Bamethane sulfate   25         mg;                                            DL-alpha-tocopherol acetate                                                                       250        mg;                                            vitamin A palmitate 10,000     I.U.;                                          soybean oil         150        mg.                                            ______________________________________                                    

EXAMPLE 37

One capsule contains

    ______________________________________                                        Vincamine             30        mg;                                           vitamin E DL-alpha-tocopherolacetat                                                                 400       mg;                                           vitamin A palmitate   30,000    I.U.;                                         soybean oil           150       mg.                                           ______________________________________                                    

EXAMPLE 38

100 g of an ointment contain

    ______________________________________                                        10          g of D-alpha-tocopherol; and                                      50,000      I.U. of heparin sodium;                                           ______________________________________                                    

in an ointment base comprising

    ______________________________________                                        22         parts of cetylstearylalcohol;                                      18         parts of Cetiol; and                                               60         parts of water.                                                    ______________________________________                                    

EXAMPLE 39

100 g of an ointment contain

    ______________________________________                                        7        g of vitamin E (D-alpha-tocopherol);                                 1        g of nicotinic acid benzyl ester; and                                1        g of camphor;                                                        ______________________________________                                    

in ointment base comprising

    ______________________________________                                        17        part of cetylstearylalcohol;                                        8         parts of white petrolatum;                                          15        parts of Cetiol; and                                                60        parts of water (aqua conservata).                                   ______________________________________                                    

EXAMPLE 40

100 g of an ointment contain

    ______________________________________                                        7           g of vitamin E,, and                                              15          g of Tinct. calendualae;                                          ______________________________________                                    

in an ointment base comprising

    ______________________________________                                        13        parts of wool wax alcohol;                                          2         parts of cetylstearylalcohol;                                       20        parts of Cetiol                                                     5         parts of paraffin; and                                              50        parts of water (aqua conservata).                                   ______________________________________                                    

EXAMPLE 41

100 g of an ointment contain

    ______________________________________                                        8    g of vitamin E (DL-alpha-tocopherol);                                    1.5  g of rosemary oil;                                                       1    g of Extract. Hippocastani (standardized to at least 8% of                    escin); and                                                              1    g juniper oil;                                                           ______________________________________                                    

in an ointment base as in Example 38.

EXAMPLE 42

Solution comprising

    ______________________________________                                        10       g of vitamin E (D-alpha-tocopherol concentrate);                     1        g of dwarf pine oil (ol. pini pumilionis);                           1        g of eucalyptus oil;                                                 1        g of juniper oil;                                                    1        g of Tween 80                                                        ______________________________________                                    

ad 100 g of isopropyl alcohol.

EXAMPLE 43

100 g of an ointment contain

    ______________________________________                                        7        g of D-alpha-tocopherol concentrate;                                 2        g of Tinct. arnicae;                                                 2        g of salicylic acid B-hydroxyethyl ester;                            ______________________________________                                    

in an ointment base as in Example 38.

EXAMPLE 44

Solution according to Example 42.

    ______________________________________                                        7.0           g of vitamin E;                                                 1.0           g dwarf pine oil;                                               1.0           g Tinct. arnicae;                                               1.0           g of Cetiol                                                     ______________________________________                                    

ad 100 g of isopropyl alcohol.

EXAMPLE 45

100 g of an ointment contain

    ______________________________________                                        9.0          g of vitamin E;                                                  20.0         g Tinct. calendulae                                              ______________________________________                                    

in an ointment base as in Example 38.

The Examples 46 through 60 relate to combinations of the vitamins E andA with lecithin.

EXAMPLE 46

One capsule contains

    ______________________________________                                        Pentoxifylline        400      mg;                                            vitamin E (D,L-alpha-tocopherol acetate)                                                            400      mg;                                            vitamin A acetate     25,000   I.U.;                                          soybean lecithin      200      mg;                                            soybean oil           120      mg; and                                        Tween 80              8        mg.                                            ______________________________________                                    

EXAMPLE 47

One capsule contains

    ______________________________________                                        Naftidirofuryl hydrogenoxalate                                                                       100     mg;                                            vitamin E (D-alpha-tocopherol-concentrate)                                                           500     mg;                                            vitamin A palmitate    30,000  I.U.                                           soybean lecithin       25      mg; and                                        soybean oil            150     mg.                                            ______________________________________                                    

EXAMPLE 48

One capsule contains

    ______________________________________                                        Cinnarizine          75       mg;                                             vitamin E (D-alpha-tocopherol acetate)                                                             400      mg;                                             vitamin A palmitate  25,000   I.U.;                                           vitamins B.sub.1, B.sub.2, B.sub.6 (in equal amounts)                                              10       mg;                                             vitamin B.sub.12     5        mg;                                             soybean oil          100      mg; and                                         soybean lecithin     280      mg.                                             ______________________________________                                    

EXAMPLE 49

100 ml of drops contain in ethyl alcohol

    ______________________________________                                        Cinnarizine    7.5          g;                                                vitamin E      4.0          g;                                                vitamin A palmitate                                                                          2,500,000    I.U. and                                          lecithin       2.5          g.                                                ______________________________________                                    

EXAMPLE 50

One capsule contains

    ______________________________________                                        Xantinol nicotinate 500       mg;                                             vitamin E (DL-alpha-tocopherol)                                                                   400       mg;                                             vitamin A palmitate 25,000    I.U.;                                           Tween 80            20        mg;                                             soybean oil         150       mg; and                                         soybean lecithin    25        mg.                                             ______________________________________                                    

EXAMPLE 51

100 ml of drops contain in ethyl alcohol

    ______________________________________                                        dihydroergotoxine methanesulfonate                                                                1.6      g (comprising                                    0,5   g of dihydroergocristine methanesulfonate,                              0,5   g of dihydroergocornine methanesulfonate,                               0,333 g of alpha-dihydroergocryptine methanesulfonate and                     0,167 g of B-Dihydroergocryptine methanesulfonate);                           vitamin E (DL-alpha-tocopherol                                                                    3.5      g;                                               acetate)                                                                      vitamin A palmitate 1,500,000                                                                              I.U.; and                                        soybean lecithin    3.5      g.                                               ______________________________________                                    

EXAMPLE 52

One capsule contains

    ______________________________________                                        B-pyridyl carbinol tartrate                                                                         360      mg                                             corresponds to 150 mg of pyridyl carbinol;                                    D-alpha-tocopherol acetate                                                                          400      mg;                                            vitamin A palmitate   10,000   I.U.;                                          soybean oil           100      mg;                                            soybean lecithin      150      mg; and                                        Tween 20              6        mg.                                            ______________________________________                                    

EXAMPLE 53

One capsule contains

    ______________________________________                                        DL-alpha-tocopherol                                                                             400        mg;                                              B-hydroxyethyl rutoside                                                                         300        mg;                                              vitamin A palmitate                                                                             30,000     I.U.;                                            soybean oil       100        mg; and                                          soybean lecithin  250        mg.                                              ______________________________________                                    

EXAMPLE 54

One capsule contains

    ______________________________________                                        Ginkgo flavoglycosides                                                                              3.0      mg                                             vitamin E (D,L-alpha-tocopherol acetate                                                             300      mg                                             vitamin A palmitate   25,000   I.U.;                                          soybean oil           100      mg; and                                        soybean lecithin      200      mg.                                            ______________________________________                                    

EXAMPLE 55

One capsule contains

    ______________________________________                                        nicotinic acid    300        mg;                                              vitamin E         400        mg;                                              vitamin A palmitate                                                                             15,000     I.U.;                                            Cetiol (Oleic acid ester)                                                                       10         mg;                                              soybean oil       100        mg; and                                          soybean lecithin  20         mg.                                              ______________________________________                                    

EXAMPLE 56

One capsule contains

    ______________________________________                                        D-alpha-tocopherol                                                                             200        mg;                                               lecithin         500        mg;                                               soybean oil      180        mg; and                                           Tween 80         10         mg.                                               ______________________________________                                    

EXAMPLE 57

Capsules in accordance with Example 56, but additionally containing15,000 I.U. vitamin A palmitate.

EXAMPLE 58

Capsules in accordance with Examples 56 and 57, but containing D,L-alpha-tocopherol acetate instead of D-alpha-tocopherol.

EXAMPLE 59

One capsule contains

    ______________________________________                                        D-alpha-tocopherol                                                                             400        mg;                                               lecithin         400        mg;                                               soybean oil      200        mg; and                                           Tween 80         15         mg.                                               ______________________________________                                    

EXAMPLE 60

Capsules in accordance with Example 59, but additionally containing15,000 I.U. vitamin A palmitate or vitamin A acetate or 9,5 mgB-carotene.

The products according to the Examples 46 through 60 can be used asagents for lowering the cholesterol level.

The following examples relate to vitamin E preparations whichadditionally contain dimethylaminoethanol.

EXAMPLE 61

One capsule contains

20 mg of dimethylaminoethanol;

400 mg of D,L-alpha-tocopherol acetate;

50 mg of soybean oil;

200 mg of soybean lecithin; and

200 mg of B-hydroxyethylrutoside.

EXAMPLE 62

One capsule contains

20 mg of dimethylaminoethanol;

400 mg of D,L-alpha-tocopherol acetate;

12,000 I.U. of vitamin A palmitate (6,67 mg);

100 mg of soybean oil;

300 mg of lecithin;

8 mg of Tween 80; and

75 mg of Cinnarizine.

EXAMPLE 63

One capsule contains

25 mg of dimethylaminoethanol orotate;

400 mg of D,L-alpha-tocopherol acetate;

15,000 I.U. of vitamin A palmitate (8.33 mg);

20 mg of soybean lecithin; and

400 mg nicotinic acid.

EXAMPLE 64

As Example 61, but with use of 8 mg of Tween 80.

EXAMPLE 65

One capsule contains

25 mg of dimethylaminoethanol orotate;

500 mg of D-alpha-tocopherol concentrate;

22,000 I.U. of vitamin A palmitate (12,22 mg);

28 mg of soybean lecithin;

120 mg of soybean oil; and

3.0 mg of Ginkgoflavoglucoside.

EXAMPLE 66

Combination according to Example 65, but with use of 8 mg of Tween 20.

EXAMPLE 67

One capsule contains

30 mg of dimethylaminoethanol orotate;

400 mg of D,L-alpha-tocopherol acetate;

300 mg of lecithin;

8 mg of Tween 80; and

30 mg of Vincamine.

EXAMPLE 68

One capsule contains

25 mg of dimethylaminoethanol orotate;

350 mg of D-alpha-tocopherol acetate;

15,000 I.U. of vitamin A palmitate;

5 mg of each of the vitamins B₁, B₂, B₆ ;

5 mg of vitamin B₁₂ ;

15 mg of nicotinic acid amide;

280 mg of lecithin; and

75 mg Cinnarizine.

EXAMPLE 69

Combination according to Example 68, but with use of 5 mg of Tween 80.

EXAMPLE 70

One capsule contains

25 mg of dimethylaminoethanol orotate;

400 mg of D,L-alpha-tocopherol acetate;

15,000 I.U. of vitamin A palmitate *8,33 mg); and

300 mg of B-hydroxyethylrutoside.

EXAMPLE 71

Combination according to Example 70, but with use of 8 mg of Tween 80.

EXAMPLE 72

One capsule contains

35 mg dimethylaminoethanol orotate;

500 mg of D-alpha-tocopherol concentrate;

22,000 I.U. of vitamin A palmitate (12,22 mg); and

400 mg of xantinol nicotinate.

EXAMPLE 73

Combination according to Example 72, but with use of 4 mg of Tween 20.

EXAMPLE 74

One capsule contains

30 mg of dimethylaminoethanol orotate;

400 mg of D,L-alpha-tocopherol acetate; and

400 mg of Pentoxyfylline.

EXAMPLE 75

One capsule contains

35 mg of dimethylaminoethanol orotate;

350 mg of D-alpha-tocopherol acetate;

15,000 I.U. of vitamin A palmitate;

5 mg of each of the vitamins B₁, B₂ and B₆ ;

5 mg of vitamin B₁₂ ; and

100 mg of Bencyclane fumarate.

EXAMPLE 76

Combination according to Example 75, but with use of 3 mg of Tween 80.

EXAMPLE 77

One capsule-contains

25 mg of dimethylaminoethanol orotate;

350 mg of D,L-alpha-tocopherol acetate;

17,000 I.U. (9,44 mg) of vitamin A palmitate;

70 mg of soybean oil; and

75 mg Cinnarizine.

EXAMPLE 78

One capsule contains

20 mg of dimethylaminoethanol;

200 mg of D,L-alpha-tocopherol acetate;

12,000 I.U. of vitamin A palmitate (6,67 mg);

50 mg of soybean oil; and

250 mg of soybean lecithin.

EXAMPLE 79

One capsule contains

35 mg of dimethylaminoethanol orotate;

400 mg of D,L-alpha-tocopherol acetate;

15,000 I.U. of vitamin A palmitate (8,33 mg); and

20 mg of soybean lecithin.

EXAMPLE 80

Combination according to Example 78, but with use of 3 mg of Tween 80.

EXAMPLE 81

One capsule contains

20 mg of dimethylaminoethanol;

200 mg of D,L-alpha-tocopherol acetate;

12,000 I.U. of vitamin A palmitate (6,67 mg); and

50 mg of soybean oil.

EXAMPLE 82

One capsule contains

35 mg of dimethylaminoethanol orotate;

400 mg of D,L-alpha-tocopherol acetate; and

15,000 I.U. of vitamin A palmitate (8,33 mg).

EXAMPLE 83

Combination according to Example 81, but with use of 3 mg of Tween 80.

EXAMPLE 84

One capsule contains

35 mg of dimethylaminoethanol orotate;

500 mg of D-alpha-tocopherol concentrate; and

22,000 I.U. of vitamin A palmitate (12,22 mg).

EXAMPLE 85

Combination according to Example 84, but with use of 4 mg of Tween 20.

EXAMPLE 86

One capsule contains

30 mg of dimethylaminoethanol orotate; and

400 mg of D,L-alpha-tocopherol acetate;

EXAMPLE 87

One capsule contains

35 mg of dimethylaminoethanol orotate;

350 mg of D-alpha-tocopherol acetate;

15,000 I.U. of vitamin A palmitate;

5 mg of each of the vitamins B₁, B₂ and B₆ ;

5 mg of vitamin B₁₂ ; and

15 mg of nicotinic acid amide.

EXAMPLE 88

Combination according to Example 93, but with use of 3 mg of Tween 80.

EXAMPLE 89

One capsule contains

25 mg of dimethylaminoethanol orotate;

350 mg of D,L-alpha-tocopherol acetate;

17,000 I.U. (9,44 mg) of vitamin A palmitate; and

70 mg of soybean oil.

In all of the Examples there was used soybean oil in an amount of from50 to 200 mg per capsule. However, other neutral oils such as olive oil,rape seed oil etc. can be used as well.

EXAMPLE 90

A solution for external application, more specifically as a spray,contains

33 parts of D-alpha-tocopherol concentrate;

8 parts of phosphorlipids;

99 parts of isopropyl alcohol;

45 parts of isopropyl alcohol (70%).

EXAMPLE 91

One capsule contains

600 mg D-alpha-tocopherol concentrate;

5,000 I.U. of vitamin A;

8 mg of Tween 80; and

120 mg of soybean oil.

EXAMPLE 92

One capsule contains

400 mg of D-alpha-tocopherol;

8.250 mg of vitamin A; and

8 mg of Tween 80.

EXAMPLE 93

One capsule contains

500 mg of D,L-alpha-tocopherol acetate;

100 mg of soybean oil;

1,000 mg of D,L-alpha-tocopherol acetate;

10 mg of Tween 80; and

150 mg of soybean oil.

EXAMPLE 94

One capsule contains

30 mg of chlorphenoxamine hydrochloride;

400 mg of D,L-alpha-tocopherol acetate;

50 mg of nicotinic acid; and

100 mg of soybean oil.

EXAMPLE 95

In accordance with Example 94, but 40 mg of chlorphenoxaminehydrochloride are used instead of 30 mg, and 20,000 I.U. of vitamin Apalmitate are added.

EXAMPLE 96

One capsule contains

70 mg of Bamipine hydrochloride;

500 mg of D-alpha-tocopherol concentrate;

100 mg of troxerutin; and

80 mg of peanut oil.

EXAMPLE 97

One capsule contains

120 mg of tritoqualine;

300 mg of D-alpha-tocopherol acetate;

100 mg of troxerutin; and

80 mg of soybean oil.

EXAMPLE 98

100 g of an ointment contain

40.0 g of clemastine hydrogenfumarate;

8.0 g of D-alpha-tocopherol concentrate; and

60,000 I.U. of heparin sodium;

in an ointment base comprising

20.0 parts of Cetiol (oleic acid oleylester);

20.0 parts of cetylstearylalcohol; and

60.0 parts of aqua conservata.

EXAMPLE 99

100 g of an ointment contain

1.5 g of chlorphenoxamine hydrochloride;

10 g of D,L-alpha-tocopherol; and

50,000 I.U. of heparin sodium;

in an ointment base as in Example 98.

EXAMPLE 100

One capsule contains

70 mg of bamipine hydrochloride;

400 mg of D-alpha-tocopherol concentrate; and

30 mg of cinnarizine.

EXAMPLE 101

According to Example 98, however including 3% of Calendulae oil.

EXAMPLE 102

100 g of an ointment contain

5 g of D-alpha-tocopherol concentrate;

10,000 I.U. of vitamin A palmitate;

50.000 I.U. of heparin sodium; and

in Eucerin anhydricum.

EXAMPLE 103

Same as in Example 102, however containing 8 g of D-alpha-tocopherolconcentrate.

The following combinations are ointments containing Bufexamac for thetreatment of skin inflammations.

EXAMPLE 104

100 g of an ointment contain

5.0 g of Bufexamac; and

8.0 g of D-alpha-tocopherol concentrate;

in an ointment base consisting of

20% of cetylstearylalcohol;

20% of Cetiol (oleic acid oleylester); and

60% aqua conservata.

EXAMPLE 105

100 g of an ointment contain

5.0 g Bufexamac; and

8.0 g of D,L-alpha-tocopherol

in an ointment base as in Example 104, however containing 55% of waterand 5% of white petrolatum instead of 60% of water.

EXAMPLE 106

100 g of an ointment contain

10.0 g of D-alpha-tocopherol;

500 mg of dexapanthenol; and

300 mg of allantoin

in an ointment base as in Example 104.

EXAMPLE 107

100 g of an ointment contain

4.0 g of Bufexamac;

8.0 g of D-alpha-tocopherol;

400 mg of dexapanthenol; and

400 mg of allantoin

in an ointment base as in Example 104.

EXAMPLE 108

Ointment as in Example 107, however Ungt. Cordes was used as theointment base.

EXAMPLE 109

Ointment as in Example 106, however triglyceride mixtures were used asthe ointment base.

The following Examples relate to vitamin E preparations containingantiallergic agents.

EXAMPLE 110

One capsule contains

30 mg of chlorphenoxamine hydrochloride;

400 mg of D,L-alpha-tocopherol acetate; and

100 mg of soybean oil.

EXAMPLE 111

In accordance with Example 110, however using 40 mg of chlorphenoxaminehydrochloride instead of 30 mg and in addition thereto 20,000 I.U. ofvitamin A palmitate.

EXAMPLE 112

One capsule contains

70 mg of bamipine hydrochloride;

500 mg of D-alpha-tocopherol concentrate; and

80 mg of peanut oil.

EXAMPLE 113

One capsule contains

120 mg of tritoqualine;

300 mg of D-alpha-tocopherol acetate; and

80 mg of soybean oil.

EXAMPLE 114

100 g of an ointment contain

40.0 g of clemastine hydrogenfumarate; and

8.0 g of D-alpha-tocopherol concentrate;

in an ointment base comprising

20.0 parts of Cetiol (oleic acid oleylester);

20.0 parts of cetylstearylalkohol; and

60.0 parts of aqua conservata.

EXAMPLE 115

100 g of an ointment contain

1.5 g of chlorphenoxamine hydrochloride; and

10 g of D,L-alpha-tocopherol

in an ointment base as in Example 114.

The following Examples relate to light-protective agents.

EXAMPLE 116

100 g of an ointment contain

8 g of D-alpha-tocopherol concentrate;

2 g of phospholipids; and

2 g of 4-phenylbenzophenone-2-carboxylic acid isooctylester

in an ointment base comprising

22 parts of cetylstearylalcohol;

18 parts of Cetiol (oleic acid oleylester); and

60 parts of water.

EXAMPLE 117

100 g of an ointment contain

3 g of hydroxyethyl salicylate;

1 g of benzyl nicotinate;

8 g of D-alpha-tocopherol concentrate; and

2 g of phospholipids

in an ointment base as in Example 116.

EXAMPLE 118

100 g of an ointment contain

50.000 I. U. of heparin sodium;

12.0 g of Arnica Lebuten extract 1=10 (alkal 60%);

7.5 g of D-alpha-tocopherol concentrate;

3 g of phospholipids;

0.5 g of linoleic acid; and

0.15 g of linolenic acid

in an ointment base as in Example 116.

EXAMPLE 119

100 g of an ointment contain

1.5 g of chlorphenoxamine hydrochlorid;

8 g of D-alpha-tocopherol concentrate; and

2 g of phospholipids

in an ointment base as in Example 116.

EXAMPLE 120

100 g of an ointment contain

10.0 g of D-alpha-tocopherol concentrate;

2.0 g of benzarone; and

2 g of phospholipids

in an ointment base as in Example 116.

EXAMPLE 121

100 g of a cream contain

10 g of D-alpha-tocopherol concentrate; and

2 g Eusolex® (8020 Merck)

in an ointment base comprising

22 parts of cetylstearylalcohol;

18 parts Cetiol; and

60 parts of water (aqua conservata).

EXAMPLE 122

100 g of a cream contain

8 g of D,L-alpha-tocopherol concentrate; and

3 g of Eusolex® (232 Merck);

in an ointment base as in Example 121.

EXAMPLE 123

100 g of a cream contain

12 g of vitamin E; and

1 g Eusolex® (8020 Merck);

in an ointment base as in Example 121.

EXAMPLE 124

100 g of a cream contain

9.0 g of vitamin E; and

0.3 g Eusolex® (8020 Merck);

in an ointment base comprising

17 parts of cetylstearylalcohol;

8 parts of white petrolatum;

15 parts Cetiol; and

60 parts of water (aqua conservata).

EXAMPLE 125

100 g of an ointment contain

8.00 g of vitamin E;

2.00 g of phospholipids;

0.50 g of linoleic acid; and

0.15 g of linolenic acid;

in an ointment base as in Example 121.

EXAMPLE 126

Ointment according to Example 121, however including 1.0 g of Eusolex®(8020 Merck) per 100 g.

EXAMPLE 127

100 g of an ointment contain

15 g of vitamin E

in an ointment base as in Example 121.

EXAMPLE 128

One capsule contains

35 mg of xanthaxanthin;

8 mg of B-carotene;

8 mg of calcium D-Pantothenate;

0.15 mg of D-biotin;

250 mg of lecithin;

400 mg of D,L-alpha-tocopherol acetate; and

80 mg of soybean oil.

EXAMPLE 129

One capsule contains

30 mg of xanthaxanthin

300 mg of D-alpha-tocopherol concentrate; and

150 mg of soybean oil.

EXAMPLE 130

One capsule contains

15 mg of B-carotene;

400 mg of D-alpha-tocopherol acetate; and

120 mg of soybean oil.

Examples 131 to 137 and Comparative Example

Eight light-protective agents as set forth hereinbelow were tested withhuman volunteers for determining the erythema-preventing activity.

EXAMPLE 131

"Vitamin E Natur" containing 8% by weight of D-alpha-tocopherol.

EXAMPLE 132

"DL Hep Na" containing 8% by weight of D,L-alpha-tocopherol and 50,000I.U. of heparin sodium.

EXAMPLE 133

"Vitamin E COO/8 55,000 Hepa Na" containing 8% by weight of naturalvitamin E and 55,000 I.U. of heparin sodium

EXAMPLE 134

"Vitamin E+COO BN 8/1.5" containing 8% by weight of natural vitamin Eand 1.5% by weight of benzyl nicotinate.

EXAMPLE 135

"8 Gew.-% Covitol und 4 Gew.-% Arnika" containing 8% by weight ofnatural vitamin E and 2% by weight of Arnica oil.

EXAMPLE 136

"8 Gew.-% Covitol

2 Gew.-% Campher

2 Gew.-% Menthol

10 Gew.-% Pfefferminzol

70 Gew.-% Lanette"

containing 8% by weight of natural vitamin E and the otheraforementioned ingredients.

EXAMPLE 137

"8 Gew.-% Covitol

10 Gew.-% Calendulae oil

74 Gew.-% Lanette"

containing 8% by weight of natural vitamin E.

COMPARATIVE EXAMPLE

"Unguentum Lanette DHW Art. 226/15270"

All products, except for the Lanette ointment, were white ointment-likeemulsions.

The products met the requirements as set for such cosmetics. They couldbe readily and uniformly applied to the skin and did not create anylayer thereon that would have any striking features of gloss, tackinessor oiliness.

During the application none of the test persons reported about anymissensations such as itch, burn or tension of the skin or any excessivefeeling of cold or heat.

Upon the examination of the skin 24 hours after the application therewere, outside the erythema reactions, no skin changes that would haveindicated any (photo)toxic (photo)allergic effects caused by theproducts.

Test Method:

The light-protective activity was determined as the average protectivefactor according to SCHULZE with 20 test persons of different ages,sexes and skin types who had healthy skin. Unless explicitly otherwisestated, the method used was that in accordance with DIN-Norm 67 501. Theproduct was uniformly applied in an amount of 150 mg/100 cm² of theskin.

Exposure to light was effected as usual by employing four lampsOsram®-Ultravitalux-Lampen at a distance of 30 cm from each other andfrom the back of the test person. The erythema threshold period of timewas recorded after about 24 hours. The individual protection factor isthe quotient of the erythema threshold period of the protected skin andthe erythema threshold period of the unprotected skin. Any intermediatevalues (e.g. 1.7; 3.4 etc.) result from the fact that the two controlareas adjacent to the test area show different erythema thresholdperiods or the test area allows a lower increase in intensity than thatof the control areas to be recorded.

Results:

In the test as thus carried out with the 20 test persons of differentages, sexes and skin types the average protection factors (underscored)as set forth hereinafter were found as the arithmetic means from theindividual measured values (given in brackets):

EXAMPLE 131

    3.28 (5×2.0; 5×2.8; 9×4.0; 1×5.6).

EXAMPLE 132

    4.38 (1×2.0; 2×2.8; 11×4.0; 5×5.6; 1×8.0).

EXAMPLE 133

    4.02 (2×2.0; 9×2.8; 6×4.0; 2×8.0; 1×11.2).

EXAMPLE 134

    4.21 (1×1.4; 5×2.0; 4×2.8; 3×4.0; 4×5.6; 2×8.0; 1×11.2).

EXAMPLE 135

    2.72 (4×1.4; 3×2.0; 9×2.8; 3×4.0; 1×5.6).

EXAMPLE 136

    2.88 (6×2.0; 10×2.8; 3×4.0; 1×5.6).

EXAMPLE 137

    3.94 (2×2.0; 5×2.8; 9×4.0; 3×5.6; 1×8.0).

Comparative Example

Lanette ointment:

    1.07 (1×0.7; 15×1.0; 4×1.4).

A commercially available preparation (Standard Preparation K 17N), whichpreviously had shown an average protection factor of 3.82 in a test with220 test persons yielded an arithmetic mean value 3.74 in the presenttest.

Due to the above data and upon comparing same with the results obtainedwith numerous test products and commercially available products underthe same conditions and in practice, the products of the Examples 131,135 and 136 are to be rated as nearly medium-active light-protectiveagents and the other products as medium-active to strongly activelight-protective agents.

While the base material, Unguentum lanette, does not have anylight-protective property as expected, the other seven products may bedivided into two groups due to their different properties, thedifferences in part being statistically significant.

The one group displays a relatively weak activity and contains eitherexclusively the natural vitamin (product of Example 131) or, in additionto 8% by weight of vitamin E, various additives (product of Example 136)or Arnica oil (product of Example 135).

In contrast hereto there is the other group the members of which aremuch more active. They either contain heparin, as the products ofExamples 132 and 133 do, or they contain 1.5% by weight of benzylnicotinate (product of Example 134) or 10% by weight Calendulae oil(product of Example 137).

These results allow several conclusions to be drawn: First it is to bestated that vitamin E in its natural form as well as in its racemic formhas a distinct light-protective activity, which apparently can still beenhanced, more specifically by the addition of heparin. A similar effectis also brought about by the addition of relatively high amount ofCalendulae oil and, surprisingly, the hyperemizing benzyl nicotinate aswell.

What is claimed is:
 1. A pharmaceutical composition effective fortreatment of skin conditions of allergy, tetter, inflammation, itch,wrinkles and damage from wounds, and for protection of skin fromultra-violet light, which is administered topically and allows vitamin Eto be resorbed into the skin and which is formulated for topicalapplication as a cream, gel, ointment, milk, lotion or solution,consisting essentially of from 0.5 to 20% by weight of vitamin E basedon the weight of the composition and at least one ultra-violet lightstabilizer.
 2. The composition according to claim 1, wherein saidcomposition contains from 4 to 10% by weight of vitamin E, based on theweight of composition.
 3. The composition according to claim 1, whereinsaid composition is formulated as a spray, tincture or solution inalcoholic solvent for topical application.
 4. The composition accordingto claim 3, wherein said solvent is isopropyl alcohol.
 5. Apharmaceutical composition effective for treatment of skin conditions ofallergy, tetter, inflammation, itch, wrinkles and damage from wounds,and for protection of skin from ultra-violet light, which isadministered topically and allows vitamin E to be resorbed into the skinand which is formulated for topical application as a cream, gel,ointment, milk, lotion or solution, consisting essentially of up to 32%by weight of vitamin E based on the weight of the composition and atleast one ultra-violet light stabilizer.
 6. The composition according toclaim 5, wherein said composition consists essentially of up to 25% byweight of vitamin E, based on the weight of the composition.
 7. Anointment for topical administration effective for treatment of skinconditions of allergy, tetter, inflammation, itch, wrinkles and damagefrom wounds, and for protection of skin from ultra-violet light,consisting essentially of from 0.5 to 20% by weight of vitamin E, basedon the weight of the composition, and at least one ultra-violet lightstabilizer wherein the ointment allows resorption of vitamin E into theskin.
 8. The ointment according to claim 7, wherein said ointmentcontains from 4 to 10% by weight of vitamin E, based on the weight ofthe composition.
 9. The ointment according to claim 7, wherein thevitamin E is in its free form.
 10. A method of treating skin conditionsin a mammal selected from the group consisting of tetter, inflammation,itch, wrinkles, damage from wounds or exposure to ultra-violet light,comprising the administration of an effective dose of a pharmaceuticalcomposition consisting essentially of from 0.5 to 20% by weight ofvitamin E based on the weight of the composition and at least oneultra-violet light stabilizer, whereby vitamin E is allowed to beresorbed into the skin.